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India Medical Device Advertising Requirements
India’s medical device advertising regulations are currently lagging a bit in terms of laws and clear guidance on the type and extent of promotions allowed for medical devices. There is no formal review and approval process but manufacturers are expected to market their products within the limits of the CDSCO approved Form MD-15, which means only claiming approved intended use(s) and not marketing products before they’ve been approved. All cover letters included with Import Licenses state:
Any literature or packing accompanying the Medical Devices or any matter stated on the label should not contravene the provisions of the Drugs and Magic Remedies (Objectionable Advertisement) Act.
Medical Device Rules, 2017
In the Medical Device Rules, 2017 and Drugs and Cosmetics Rules, 1945, under the Drugs and Cosmetics Act 1940, there are no specific provisions/sub-rules pertaining to Advertising and Promotion of Medical Devices. However, under the Section 3 – Definitions, the definition of “intended use” is included as under– (v) “intended use” means the use for which the medical device is intended according to the data supplied by the manufacturer on the labelling or in the document containing instructions for use of such device or in promotional material relating to such device, which is as per approval obtained from the Central Licensing Authority;
Therefore, all promotional material related to the device should be as per the intended use for which the device is approved by the CDSCO.
Draft Advertising Guidance
India has been working towards reforming their advertising requirements and currently have 2 regulations in the works. While the Uniform Code will likely remain voluntary, the Drugs and Magic Remedies Amendment is expected to come with penalties.
Draft Drugs and Magic Remedies Amendment
At this time, guidance is only in draft form per Draft Drugs and Magic Remedies (Objectionable Advertisements) Amendment Bill 2020 (MOH link), released on 03 February 2020. It was enacted by the Ministry of Health and Family Welfare (MOHFW) and Government of India to govern the advertising and promotional activities for ‘drugs’, which include ‘medical devices’ under their ambit. According to the Draft Drugs and Magic Remedies (Objectionable Advertisements) Amendment Bill 2020, the definition for an Advertisement is amended:
Under Section 2, Clause (a) – “advertisement” means any audio or visual publicity, representation, endorsement or pronouncement made by means of light, sound, smoke, gas, print, electronic media, internet or website and includes any notice, circular, label, wrapper, invoice, banner, poster or such other documents:
Provided that label or wrapper is an advertisement only if it contains any information or claim other than provided in the rules.”
The amendment increases the scope of the word “advertisement” by including electronic media, internet or websites as well as notices, circulars, labels, wrappers, invoices, banners, and posters. With this revised scope, promotion of medical devices via social media is also covered.
Draft Uniform Code for Medical Devices Marketing Practices (UCMDMP)
The UCMDMP, prepared by the Department of Pharmaceuticals (DoP) under the Ministry of Chemicals and Fertilizers, is expected to act as guidance to the industry for promotion and marketing of medical devices and pharmaceuticals. These guidelines are voluntary and do not have the force of law and are applicable on pharmaceutical and medical device companies. The Medical Technology Association of India (MTAI) has been tasked with the job of finalizing the draft with consensus of all industry associations. MTAI presented the revised draft to the DoP in November 2021 and the final version/ further deliberation is awaited from the Government. The Draft Uniform Code can be found here.
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Contact Asia Actual if you’d like to receive a more in depth summary of the transitioning requirements in India and to be alerted as new updates are released.
Asia Actual is a regulatory consulting company specializing in helping manufacturers grow their sales through independent license holding, direct fulfillment, and a variety of sales channel support services.
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